Intersect ENT (NSDQ:XENT) said today it won FDA approval for its Sinuva mometasone furoate sinus implant designed to treat recurrent nasal polyp disease in patients who have previously had ethmoid sinus surgery. The Sinuva device is designed to be implanted during a routine physician office visit and expands into the sinus cavity to deliver an anti-inflammatory steroid […]

Entellus Medical (NSDQ:ENTL) said today that it struck a deal to be acquired by Stryker (NYSE:SYK) for $662 million in cash. Plymouth, Minn.-based Entellus, founded in 2006, makes a family of minimally invasive balloon device products, including its flagship Xpress device, that are designed to treat blocked sinuses. Earlier this year it closed the $81 million […]

EndoGastric Solutions said this week it launched the EsophyX Z+ device designed for use in transoral incisionless fundoplication procedures to reconstruct the gastroesophageal valve to treat patients with severe gastroesophageal reflux disease. The device is designed to be used with a partial fundoplication technique that secures tissue with dual deployment of SerosaFuse implantable fasteners, the […]

The FDA last week approved remote programming adjustments for Cochlear Ltd.‘s (ASX:COH) Nucleus cochlear implant, removing the need for a select group of users to make repeat visits for in-person programming sessions. The newly-cleared remote programming feature is indicated for patients with 6 months of experience with their cochlear implant sound processors and who are […]

Advanced Bionics said late last week it won FDA approval for its HiFocus SlimJ electrode designed for use with the company’s HiRes Ultra cochlear implant. The Valencia, Calif.-based company touts the new electrode as featuring a thin, straight design for easier insertion during procedures and a slim profile to protect the delicate structures of the […]

Shares in Pavmed Inc. (NSDQ:PAVM) rose today after the medical device maker beat expectations on Wall Street with its third quarter results. The N.Y.-based company posted a net loss of -$5.37 million, or -40¢ per share, for the 3 months ended Sept. 30, for bottom-line loss of -178.5% compared with the same period last year. Get the […]

EndoGastric Solutions said today that new Medicare Administrative Contractors Noridian Health Care Solutions and National Government Services have been granted reimbursement access for the transoral incisionless fundoplication procedure using its Esophyx device. The Redmond, Wash.-based company’s TIF procedure is designed to prevent stomach acids refluxing back into the esophagus by reconstructing the gastroesophageal valve. Noridian, […]

Intersect ENT (NSDQ:XENT) said today that the FDA performed a pre-approval inspection of the company’s Menlo Park facility as part of the new drug application for the its Sinuva steroid-releasing sinus implant. Although the FDA issued a form 483 with four inspection-related observations, the company said it doesn’t expect these notes to impact its Jan. 7 […]

Millions of people around the world are losing their hearing thanks to inner ear disorders and the pharmaceutical industry has spent years working to develop therapeutics to help address this patient population. But Jeff Borenstein, lead scientist for drug delivery at Draper, discovered by talking to experts in the hearing loss field that many of […]

Shares in Intersect ENT (NSDQ:XENT) rose slightly today after the steroid-eluting implant maker beat sales expectations on Wall Street with its third quarter results. The Menlo Park, Calif.-based company posted a net loss of -$4.3 million on sales of $22.3 million for the 3 months ended Sept. 30, for sales growth of 21% compared with the same period last […]

Inscope Medical Solutions said today it launched its Inscope Direct laryngoscope with integrated, controllable suction, touting it as the 1st of its kind. The Inscope Direct device is designed to eliminate the need to move between yankauer suction and the endotracheal tube while securing the airway, the Washington D.C.-based company said. “Using the Inscope Direct […]